Theralase Technologies Inc. V.TLT

Hemerion Planning Phase 2 Trial at Mt. Sinai NY in 2022

[Eoganacht]

In 2022, in collaboration with Hemerion Therapeutics, Drs. Yong and Hadjipanayis of Mount Sinai Hospital, New York will begin a phase 2 clinical trial of intraoperative photodynamic therapy for GBM patients after tumour resection using the photosensitizer 5-ALA, which is already approved by the FDA for fluorescence-guided surgery in glioma patients.

Hemerion is hoping the treatment will become the standard of care by late 2026.

On 12 January 2017, orphan designation was granted by the European Commission to Centre Hospitalier Universitaire de Lille, France, for 5-aminolevulinic acid for the treatment of glioma.

The sponsorship was transferred to Hemerion Therapeutics, France, in December 2020.

Orphan designation has many advantages and one of them is ten years of market exclusivity.

In Europe at least, authorised orphan medicines benefit from ten years of protection from market competition with similar medicines with similar indications once they are approved.

[fredgoodwinson]

Interesting that Eog. The vaccine farce and their disgraceful treatment of AZ looks unlikely to be the only case where the naked protectionism of the EU leads to poor health outcomes for those under its`control. Should we take it from your last para that those in Europe with GBM would now have to travel to Toronto if they wished to be treated with Rutherrin? Chinese disregard of patents is one

[gojotv!]

Ah, but here's an interesting question... What if Rutherrin proves to be more effective than 5-ALA in treating glioblastoma, ensuring longer survivability and triggering an anti-cancer immune response? All opposition to using it in Europe would melt away, that's what. So, I'm hardly concerned, lol.  

[fredgoodwinson]

The sad reality is that there`s no opposition to its`use among consumers to start with but if you think that the EU are going to roll over and fail to protect their Company from Competition just because more lives could be saved then watch this space...

[gojotv!]

Ah, don't forget... The EU has socialized healthcare. If keeping a soon-to-fail company afloat costs the government money while creating a public outcry... All bets are off.  

[fredgoodwinson]

Not sure that it works like that.

[Eoganacht]

What would be crazy would be if Hemerion accomplishes their aim of attaining marketing authorization for ALA for glioma in Europe by 2026 and is granted confirmation of their orphan status and Theralase comes out with a much better FDA approved treatment a couple of years later. Would Theralase be frozen out of the European glioma treatment market because Hemerion is protected from competition for

[enriquesuave]

Im not sure Theralase would be in direct competition as Rutherin would probably be used with X-ray activation instead of surgery or both light and X-ray activation with only small cranial incisions to place fibre optics, also instead of surgery.  Hemerion is working on an intra operative procedure which would be done right at the end of surgery for GBM tumors.  So different indications

[Eoganacht]

I hope you're right, and you probably are, but the vagueness of the wording from the European Medicines Agency makes me uneasy. "Orphan medicines benefit from ten years of market exclusivity once they receive a marketing authorisation in the European Union (EU). This measure is intended to encourage the development of medicines for rare diseases, by protecting them from competition from

[langosta]

 similar medicines with similar indications, which cannot be marketed during the exclusivity period.". That kind of wording is a cop out. Would that stand up in a court ? I doubt it.

[O12009]

Could we not open a clinic and treat people from all over the world. Canada would become a medical tourism hot spot. 

[99942Apophis]

Hi 012009 if they do it wouldn't be the first specialized clinic in Canada to have patients from other countries. Wen I went to the Shouldice Hospital Toronto for my Hernia surgery I met other patients many came from Europe so it probably would be as you say open to medical tourism bringing their Euro dollars.

[CancerSlayer]

If there's a better option out there, people will come....especially if the option is more patient-friendly &/or competitively priced.  People will pay/travel if it means staying alive & well.  They could then return home for any additional adjuvant or maintenance radiological/medical treatments.  I also don't think such an exclusivity clause holds water

[CancerSlayer]

  Surgery-free/transcranial x-ray activation would be ideal.  Unfortunately, I don't think current radiological technology would be able to achieve the results TLT desires/deserves for its promising compound.  In order to maximize tumor destruction & improve overall survival, intracranial surgery will generally play a major role.  However, such a hidden/immune

[Infinity]

Interesting thoughts from cancer slayer, enrique and Eoganacht.   I believe, ALA as a transferin was tried in earlier test by TLT.  Dr. Mandel and Dr. Lilge decided to go with Rutherin.  Hemerion could be an indirect competition and both companies will benefit from each other's research and test results.   Hopefully Hemerion clinical tests at Mt. Sinai will ignite

[menoalittle]

wow... 382 reads on that post in only 4 hours. seems there's an increasing number of eyes on this one lately.

[Lesalpes29]

Interest is on! And the SP really stable. Probably ready to go up from here.

[Infinity]

While Hemerion is working on brain cells specifically Glio-blastoma,  Lumeda is also working on NSCLC and their clinical test results will be published.  Exact same technology, PDT using photfrin. Would like an opinion and possibly an educated discussion, on how these two researches will play out. https://lumedainc.com/clinical-studies-list/

[Eoganacht]

Hi Fred - I don't think this is about protectionism, it's about orphan designation for 5-ALA for the treatment of glioma.The purpose of orphan designation is to encourage the development of medicines for rare diseases by providing incentives such as market exclusivity. The EMA made the decision to grant this status to 5-ALA for the treatment of glioma in January 2017 based on the

[fredgoodwinson]

Thanks Eog - to you and GoJo. Orphan status makes sense in relation to the high cost of developing effective treatments for relatively low volume but nonetheless devastating diseases.It sensibly encourages research by Companies who in the event of success can expect to be not only compensated but fairly rewarded but it is a question of degree. Is 10 years` really a reasonable timescale during